1. Field of the Invention
The invention relates to a device for introducing a diaphragm into a vagina, as well as for placing it in front of the womb. More particularly, the invention relates to a device having a hollow insertion rod with a longitudinally slotted, open insertion end to which a diaphragm can be detachably fixed which is arranged in a piston displaceable relative to the insertion rod.
2. Description of the Prior Art
As is known, a diaphragm constitutes a contraceptive means, which is inserted in the vagina and positioned in such a way that it seals it off from the womb. As a result the male spermatozoa cannot enter the oviduct, so that fertilization cannot take place. In addition to this mechanical protection, a spermicidal cream, foam or gel is used, which renders the male spermatozoa infertile within a very short time. The conventional diaphragm, in both the stocked state and in the fitted state, is circular and geometrically spherically segmental in plan view and comprises an elastic membrane reinforced in bead-like manner on the edge portion. For insertion purposes, the diaphragm is deformed by lateral compression of the bead at two facing points. This automatically forms two pockets. The automatically formed pockets (and optionally the bead-like edge) then are filled or coated with spermicidal agent such as spermicidal cream or the like.
Although this contraceptive device and method has been known for many years, it has not been as widely used as might have been expected. This is particularly due to the fact that difficulties are encountered in inserting a diaphragm unless aids are used. Furthermore, the coating or partial filling with spermicidal cream or the like leads to both the fingers and the vagina becoming smeared with the spermicidal agent, which is considered to be unpleasant and/or disturbing.
To facilitate the introduction of a diaphragm, an insertion rod has been developed and is known, which is provided at its one end with a slight notch onto which a diaphragm can be fixed prior to introduction and placement in the vagina. For the purpose of this fixing, several additional notches are provided in the central region of the known insertion rod to accommodate different diaphragm sizes. The opposite portion of the bead-like edge can be fixed to one of these notches in the central region of the insertion rod in such a way as was described hereinbefore in connection with manual insertion. In the case of the conventional insertion rod, the diaphragm is taken into the hand in such a way that its curvature points outward and is laterally compressed in the aforementioned manner. Following fixing at the insertion end and in the central portion of the insertion rod, the two aforementioned pockets described in conjunction with manual insertion are formed and filled with the spermicidal agent. It is also recommended that the bead-like edge be coated with cream or the like, in order to improve slidability during insertion.
For insertion and positioning the diaphragm, the insertion rod with the fixed and correspondingly prepared diaphragm is inserted and moved tightly along the lower vagina base up to and behind the opening and is then turned to the side to detach the diaphragm from the insertion rod. This permits the insertion rod to be removed from the vagina. The front edge of the diaphragm is then forced upwards with a finger in such a way that it is positioned behind the pubic bone, where its location is such that it completely covers the opening.
It is readily apparent that, with the conventional insertion rod as the insertion aid, the reservations against this extremely reliable and acceptable contraceptive means cannot be eliminated because the complete handling procedure is still very complicated and because large numbers of potential users object to it. Furthermore, even during the use of this insertion rod, it is not possible to prevent a considerable portion of the spermicidal agent from reaching points where it is not necessary and considered unpleasant and disturbing.
In order to facilitate introduction, U.S. Pat. No. 2,008,380 discloses a device in which the insertion end of the insertion rod is constructed as a head, which is considerably thickened compared with the remaining insertion rod portion. The head is roughly of the same length as the radius of a flexible diaphragm, so that one-half of the diaphragm can be compressed and can be inserted in the insertion head, the other half of the diaphragm projects from the device in an only partially deformed state compared with its normal shape. Even under favorable insertion conditions, a precise positioning of the diaphragm in front of the womb is extremely difficult. Because the diaphragm is flexible, in the case of this conventional device, it can be easily bent sideways during insertion. Under unfavorable circumstances the diaphragm may not even be inserted in the vagina.
In addition, using this device, the spermicidal agent with which the diaphragm is provided comes into contact with the walls of the vagina during insertion, so that part of the spermicidal agent is transferred to the vagina walls. In this known device there is a functionless slot on its underside, which can lead to irritation or even to injuries to the vaginal tissue during insertion.
U.S. Pat. No. 2,141,040 discloses a diaphragm insertion device comprising a cylindrical insertion rod and a cross-sectionally cylindrical piston. This is difficult and unpleasant to insert because the diaphragm must be provided with the spermicidal agent prior to reception in the device, so that said agent necessarily also gets on to the user's fingers. This device is not only anatomically unfavorable, but also unreliable because the user cannot detect from the outside in which relative rotation position with respect to the longitudinal axis she must insert the insertion rod.
U.S. Pat. No. 4,398,532 discloses a diaphragm insertion device with a hollow insertion rod and a piston. The insertion rod has a relatively flat construction and contains both the diaphragm and spermicidal agent. The insertion end of the rod is initially closed by a cap. This known device is intended only for a single use, which, in view of the considerable costs of a diaphragm, is unacceptable for widespread use.
Finally, West German Application No. 17 66 697 discloses a diaphragm insertion device, in which the insertion end portion of a hollow insertion rod contains a multiply folded or rolled up diaphragm which, after expulsion, opens out in such a way that it is correctly positioned in front of the womb. Here again, the diaphragm must initially be provided with spermicidal agent permitting an increased amount of the spermicidal agent to be transferred to the user's fingers, because the diaphragm is not only laterally compressed, but is also deformed. This orientation is also disadvantageous in connection with a correct positioning in front of the womb.
Thus, it is desirable to so improve the known diaphragm insertion devices while avoiding their disadvantages so that insertion can take place effortlessly and without difficulty, even when used for the first time by a relatively unskilled or inexpert user. It is also desirable to provide a diaphragm insertion device in which the diaphragm is inserted in such a way that the diaphragm is correctly positioned in front of the womb while simultaneously ensuring that those vaginal areas where no spermicidal agent is required, as well as a user's fingers do not come into contact with the agent. In addition, the device must be reusable a random number of times and, therefore, easy to clean.